Cleared Traditional

K152945 - Alevicyn SG Antipruritic Gel

K152945 · Oculus Innovative Sciences · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
70d
Days
-
Risk

K152945 is an FDA 510(k) clearance for the Alevicyn SG Antipruritic Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oculus Innovative Sciences (Petaluma, US). The FDA issued a Cleared decision on December 15, 2015 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K152945

510(k) Number K152945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2015
Decision Date December 15, 2015
Days to Decision 70 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 115d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 638
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